Fix biosolutions legislative landscape or lose talent and scale-ups, says strategist

Investors champion biotechnology with AI as the engine of the Fourth Industrial Revolution, but despite Europe’s strong ambitions biotech analysts say legislation designed for chemicals is not fit for the biological. The result is an exodus of talent and investment.

Europe’s biotech landscape is “incredibly strong” says Tim Zandbergen, strategic policy advisor at Dutch entrepreneurs’ association VNO-NCW. But he told Euractiv that “the actual application of biotechnology into products, services and treatments in Europe is lacking.”

While Zandbergen cites CRISPR-Cas9 as one of the key new biotechnologies – discovered in The Netherlands – the weakness of application “is mostly because European legislation is outdated – GMO is from a 2001 directive – and many bio-solutions still fall under chemical legislation, which simply is not adequate for biology.”

Biosolutions new manifesto

To boost Europe’s competitive capacity and address the EU’s outmoded legislative format, the European Biosolutions Coalition has proposed a new manifesto including six policy recommendations to establish a green and bio-based paradigm, while enabling delivery of the EU Green Deal.

The Coalition advocates investing in research, development, and innovation to develop new biosolutions and keep up with other economies. They suggest integrating biosolutions into the future Horizon program and revising the Common Agricultural Policy.

Secondly, they seek to improve investment incentives to accelerate market entry of biosolutions – the Coalition recommends improving investment incentives, particularly for SMEs struggling to finance infrastructure scaling. They suggest exploring the use of IPCEI funds for bio-reactors and developing a model for EU co-investment in public-private partnerships.

Fair classification, fast approval

In addition, the EBC wants to ensure fair EU classification for the recognition of biosolutions in the EU classification of economic activity, the NACE codes. They propose including biosolutions in the EU taxonomy to increase access to sustainable finance for biosolutions companies.

Developing a risk-benefit approach is favoured, and the EBC suggests introducing a risk-benefit analysis framework to guide regulatory decisions, considering both the potential benefits and disadvantages of biosolutions.

In addition, the development of a European market access model is proposed based on a GRAS-inspired approach for market access, where companies must demonstrate and gain expert consensus on the safety of new biological solutions.

And finally, the sixth policy principle in the manifesto is for Europe to develop a fast approval framework – a new horizontal framework for faster approval of sustainable biosolutions. They suggest moving from a process-centric to a product-centric approach, building on a risk-benefit approach, and ensuring regulatory sandboxes for the development, testing, and validation of innovative technologies.

Export capability

Asked by Euractiv about Europe’s biotech export capability, Zandbergen said: “Export capacity is not an issue, most of the actual COVID vaccine doses were manufactured in the EU, for example.”

“Another good example,” he explained, is cultivated meat “which allows for growing real meat from real meat cells, but without the animal suffering and the huge amounts of food, water and space that cattle require (…) This is truly a disruptive revolution!”

Ferdinand Los, CEO of Hudson River Biotechnology said: “EU regulation in our field has been slow to change, in part because of a strong influence from organizations that push back against innovation.”

“You see more forward-looking regulation – and speed of implementation – and investments, for example in the Americas, which has caused industry innovations to develop there at a much faster pace than in Europe.”

Los added: “Meanwhile, we have F&A-related issues here, like farmers who are discontent with regulations and quotas, with a desire but practical inability to reduce or phase out agrochemicals. The only way to solve such issues for the long term is through innovation.”

Born in Europe, grow-up in the USA, Asia

Zandbergen remarked: “EU law on GMO and Novel Foods require such extensive and expensive processes currently, which are simply not feasible for the many high-tech startups if they are allowed to be marketed at all – which cultivated meat isn’t yet.”

“So, these companies move to the US or Singapore. As I say it – these companies are born in Europe, but they grow up in the US and Asia. Therefore, a political focus on modernising European legislation around biotechnology is required urgently.”

In terms of legal bottlenecks, Zandbergen said that since 2001 there have been a lot of strides in biotechnology, yet legislation has not kept up.

“Unfortunately, we see the legislative process grind down because of the deeply technical nature of this topic,” he explained, “which shows the need for science-based arguments to come to the front of this debate. Science has shown these modern technologies to be as safe, if not safer, than older methods. On top of that, they are cheaper and much more efficient.

Fernando Los argues “In terms of landscape, I think Europe is good at generating inventions and building startups but lacks in helping promising startups mature and grow and become competitive on an international scale. The latter is where I think more focus should be in terms of government support – push more grants and investments into this part of the industry, and using simple funding instruments.”

Zandbergen adds that “The EU has set out great ambitions in terms of strategic autonomy, high-tech business strength and growth and dominance in key technologies. Biotechnology is, together with AI, the engine of this Fourth Industrial Revolution. But, strong ambitions should be backed by a strong capacity to execute.”

[By Brian Maguire | Euractiv’s Advocacy Lab ]

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